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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

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Human medicine European public assessment report (EPAR): Aspaveli

Pegcetacoplan, Hemoglobinuria, Paroxysmal
Date of authorisation: 13/12/2021, , , Revision: 3, Authorised, Last updated: 06/09/2022
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Human medicine European public assessment report (EPAR): Atriance

nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007, , , Revision: 26, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): ATryn

Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006, , , Revision: 16, Withdrawn, Last updated: 02/07/2019
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Human medicine European public assessment report (EPAR): Aybintio

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020, , , Revision: 6, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)

avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020, , , , Revision: 6, Authorised, Last updated: 14/03/2023
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Human medicine European public assessment report (EPAR): Bavencio (updated)

avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017, , Revision: 15, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Benlysta

belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011, , Revision: 29, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Beovu

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 6, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Besponsa

inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017, , Revision: 9, Authorised, Last updated: 16/03/2022
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Human medicine European public assessment report (EPAR): Besremi

ropeginterferon alfa-2b, Polycythemia Vera
Date of authorisation: 15/02/2019, , Revision: 4, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Beyfortus (updated)

nirsevimab,
Date of authorisation: 31/10/2022, , Revision: 1, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Bimzelx

bimekizumab, Psoriasis
Date of authorisation: 20/08/2021, , Revision: 2, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): BindRen

colestilan, Hyperphosphatemia
Date of authorisation: 21/01/2013, , Revision: 2, Withdrawn, Last updated: 01/04/2015
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Human medicine European public assessment report (EPAR): Blenrep

belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020, , , , Revision: 4, Authorised, Last updated: 12/10/2022
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Human medicine European public assessment report (EPAR): Blincyto (updated)

blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015, , , Revision: 16, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Braftovi

Encorafenib, Melanoma; Colorectal Neoplasms
Date of authorisation: 19/09/2018, , Revision: 10, Authorised, Last updated: 05/08/2022
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Human medicine European public assessment report (EPAR): Bretaris Genuair

aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/07/2012, , Revision: 18, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Breyanzi

CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022, , Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Brimica Genuair

formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014, , Revision: 13, Authorised, Last updated: 04/01/2023
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Human medicine European public assessment report (EPAR): Brineura

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Brukinsa (updated)

zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021, , Revision: 5, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Byfavo

remimazolam, Conscious Sedation
Date of authorisation: 26/03/2021, , Revision: 4, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Bylvay

Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021, , , , Revision: 2, Authorised, Last updated: 05/10/2022
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Human medicine European public assessment report (EPAR): Byooviz

ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021, , , Revision: 5, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Cablivi (updated)

Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018, , , Revision: 7, Authorised, Last updated: 14/03/2023